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Completed

NCT Number: NCT00122356

Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment

The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are receiving anastrozole therapy, and to determine how long alendronate treatment is needed.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sydney South West Area Health Service, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal
  • Adequately diagnosed and treated Stage I-IIIa early breast cancer
  • Oestrogen receptor and/or progesterone receptor positive breast cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  • Hormone replacement therapy (HRT) must be discontinued at least 2 weeks prior to registration
  • Any prior tamoxifen taken for a total of 8 weeks or less
  • Any prior anastrozole taken for a total of 4 weeks or less
  • Anastrozole is clinically indicated to be the best adjuvant strategy
  • Signed written informed consent

Exclusion criteria

  • Clinical or radiological evidence of distant spread of disease
  • Prior treatment with bisphosphonates within the past 12 months
  • Prior treatment with continuous systemic corticosteroids within the past 12 months
  • Prior use of parathyroid hormone for more than 1 week
  • Prior use of systemic sodium fluoride for > 3 months during the past 2 years
  • Currently treated with any drugs known to affect the skeleton
  • Abnormal renal function (serum creatinine greater than or equal to 265.2 mmol/L)
  • History of diseases with influence on bone metabolism. Patients with lactose intolerance are also excluded
  • Delayed oesophageal emptying such as stricture or achalasia
  • Hypersensitivity to alendronate or anastrozole
  • Previous or concomitant malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
  • AST/SGOT and/or ALT/SGPT > 3 x ULN in combination with other laboratory and clinical abnormalities indicating liver insufficiency
  • Fracture due to minimal trauma, demonstrated radiologically

Treatment and study plan

Alendronate sodium

Drug

70mg tablets, once weekly

Other names: Fosamax, Alendro, Adronat

Primary outcomes

  1. Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment

    Time frame: 5 years

Secondary outcomes

  1. Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD

    Time frame: 12 monthly intervals

  2. Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD

    Time frame: 6 months after registration and/or 6 months after commencing alendronate

  3. Evaluate the Osteoporosis Australia strategy for bone protection for this patient group

    Time frame: 5 years

  4. Evaluate the clinical fracture incidence cumulative over 5 years

    Time frame: 5 years

  5. Perform an economic analysis of the cost of monitoring and intervention

    Time frame: 5 years

  6. Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy

    Time frame: 5 years

  7. Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Barwon Health

Other Gov

Collaborators

  • AstraZeneca

Registry information

Official study title

Maintaining Skeletal Health in Postmenopausal Women With Surgically Resected Stage I-IIIa Hormone-receptor Positive Breast Cancer Who Are Receiving Anastrozole, Through the Use of Alendronate as Determined by the Osteoporosis Australia Bone Maintenance Algorithm

Acronym: BATMAN

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Jul 22, 2005
Registry last updated
Mar 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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